Corporate Overview
AVIcure Bioscience, LLC.
Confidential
Overview: AVIcure BioScience, LLC.
• AVIcure develops, manufactures and markets patented medical devices for:
– Blood comp...
Company Strengths
• Deep pipeline addresses high need market segments:
– Blood pathogen reduction
– Immune system stimulat...
4
The Blood Management Company
Confidential
AVIcure Focus
AVIcure designs, develops and
manufactures medical devices using...
AVIcure Portfolio – focus on blood purification
5
5 Private and Confidential
Product Indication Research Preclinical Clini...
6
The HemaSterilizer™
HemaSterilizer (HS) technology provides a medical device
platform designed to inactivate pathogens i...
Market Need: Blood Safety
Viral disease transmission
• Improved but still present
– <than 1:1M transfusions for HIV, 1:250...
The HemaSterilizer™ Concept
• Device exposes concentrated red blood
cells (CRBC) to an Ultraviolet C (UVC) light
source
• ...
The HemaSterilizer™ System
9
9 Private and Confidential
Why the HemaSterilizer™ System Will Perform
• UVC was shown to reduce the levels of
purposely contaminated red cells with ...
Comparison: HemaSterilizer vs.
Other RBC Sterilization Methods
• Uses known principles to
achieve inactivation without
dru...
Status & Next Steps
• Phase 1 prototype model available for testing
• Preclinical Studies
– Demonstrate inactivation of pa...
13
The ImmunoModulator™
First-in-class patented ImmunoModulator (IM) technology
designed to address life threatening RNA v...
Market Need: Hard-to-Treat Diseases
• Hepatitis C
– 3.2 million patients in U.S.
– 170 million patients worldwide
• Human ...
The ImmunoModulator™ Concept
• IM device exposes the patient’s whole blood to an
Ultraviolet (UV) light source
– Treatment...
The ImmunoModulator™ System
• ImmunoModulator (IM) technology developed to utilize broad band ultraviolet light
(200nm-400...
The ImmunoModulator™ System
17
17 Private and Confidential
USE IMAGE FROM POSTER
Clinical Studies/Data
Data to date:
• Hepatitis C
– Granted two IDE approvals by FDA for human non-responder trials
– Safe...
Future
• Influenza Study
• Mycobacterium Avian Complex (MAC) Study
19
19 Private and Confidential
Mechanism of Action
• Vi...
20
• Todd Kuenstner, CEO and Chief Medical Officer. Dr Kuenstner is a pathologist who is currently the
Medical Director or...
21
• Dennis J. Losco, Controller. Graduated from Farleigh Dickinson in 1991 with a degree in Business Management.
Joined S...
22
• Preston A. Marx, PhD. He is a Professor of Tropical Medicine at the Tulane School of Public
Health and Tropical Medic...
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AVICureBiosciencePPT4

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AVICureBiosciencePPT4

  1. 1. Corporate Overview AVIcure Bioscience, LLC. Confidential
  2. 2. Overview: AVIcure BioScience, LLC. • AVIcure develops, manufactures and markets patented medical devices for: – Blood component pathogen reduction ( 10-6 sterilization ) – Immune System Stimulation – Pulse Radio Frequency (Pain Relief) • Founded in 2013 • Located in Bethlehem, PA • Total employees: 8 • Capitalization: – Funding from initial investors – Private Placement – Sale of Assets – Corporate Sponsorship 2 2 Private and Confidential
  3. 3. Company Strengths • Deep pipeline addresses high need market segments: – Blood pathogen reduction – Immune system stimulation • Strong IP position • A strong management team and advisers with scientific and business expertise to execute company business plan 3 3 Private and Confidential
  4. 4. 4 The Blood Management Company Confidential AVIcure Focus AVIcure designs, develops and manufactures medical devices using advanced ultraviolet light technology. The devices, though different in application, use ultraviolet light to stimulate the immune system and reduce blood borne pathogens providing for both therapeutic and preventative applications.
  5. 5. AVIcure Portfolio – focus on blood purification 5 5 Private and Confidential Product Indication Research Preclinical Clinical Trials Marketed Market Opportunity HemaSterilizer™ Blood Pathogen Inactivation $2.5 Billion (US) and $7.5 Billion (Global) ImmunoModulator Chronic viral infections $12.3 Billion (US; for Hepatitis C and influenza) AVIcure™ Device Chronic temporomandibular joint (TMJ) pain and anterior knee pain $300 Million (Global)
  6. 6. 6 The HemaSterilizer™ HemaSterilizer (HS) technology provides a medical device platform designed to inactivate pathogens in Red Blood Cell (CRBC) concentrates intended for transfusion using UV light technology. Confidential Pipeline Products - HemaSterilizer™
  7. 7. Market Need: Blood Safety Viral disease transmission • Improved but still present – <than 1:1M transfusions for HIV, 1:250,000 for hepatitis C, and 1:500Kfor hepatitis B • Emerging viruses – Ebola virus, West Nile virus, human herpes virus 8, and several small DNA viruses (TTV, SEN-V) • Microbial contamination • Approved inactivation protocols lacking – No completely reliable method for pathogen inactivation in donated blood components and whole blood in US • Potential safety and blood component recovery issues – Immune reactions, reduced RBC recovery and survival 7 LACK OF ACCESS TO SAFE BLOOD WORLDWIDE No completely reliable pathogen inactivation system available 7 Private and Confidential
  8. 8. The HemaSterilizer™ Concept • Device exposes concentrated red blood cells (CRBC) to an Ultraviolet C (UVC) light source • Designed for use in a blood bank • Uses proprietary design to minimize handling and achieve sterilization acceptance • Initial Phase 1 bench testing 8 8 Private and Confidential
  9. 9. The HemaSterilizer™ System 9 9 Private and Confidential
  10. 10. Why the HemaSterilizer™ System Will Perform • UVC was shown to reduce the levels of purposely contaminated red cells with no adverse effect. • Initial inactivation goal is 5 Log with <1% hemolysis. • AVIcure’s Bench laboratory test results: – RBC Concentration inactivation test achieved 6 Log reduction with some induced hemolysis. 10 10 Private and Confidential
  11. 11. Comparison: HemaSterilizer vs. Other RBC Sterilization Methods • Uses known principles to achieve inactivation without drugs/chemicals • Inactivates all known viruses • Excellent recovery and survival of RBCs • Relative ease of use • Require potentially toxic chemicals (PEN110, Dimethylmethylene blue, Riboflavin, Psoralen, S-303, others) • Immunogenicity (S-303) • Lack of efficacy against some pathogens (PEN110 against TTV and SEAN-V) • Reduced RBC recovery and survival • Complicated use 11 HemaSterilizer “Other” Systems 11 Private and Confidential
  12. 12. Status & Next Steps • Phase 1 prototype model available for testing • Preclinical Studies – Demonstrate inactivation of pathogenic (model) viruses >5 logs with <1% hemolysis – RBC recovery and survival after 42 days storage – <1% hemolysis after 42 day standard storage – Assess immunogenicity • Clinical Studies with Sponsorship – Phase I, II and III human clinical studies designed to demonstrate safety 12 12 Private and Confidential
  13. 13. 13 The ImmunoModulator™ First-in-class patented ImmunoModulator (IM) technology designed to address life threatening RNA viruses, “autoimmune” diseases (e.g. Psoriasis) and potentially other illnesses by treating whole blood with ultraviolet (UV) photopheresis Confidential Pipeline Products - ImmunoModulator™
  14. 14. Market Need: Hard-to-Treat Diseases • Hepatitis C – 3.2 million patients in U.S. – 170 million patients worldwide • Human HIV – 1.1 million patients in U.S. – 33.4 million patients worldwide • H1N1/Influenza – < 200,000 hospitalized in U.S. annually – 3-5 million severe cases reported worldwide • Psoriasis – 4.5-7 million patients in U.S. – 125 million patients worldwide • MAP (Mycobacterium Avium Paratuberculosis) – Role in Crohn disease (CD), Type 1 diabetes mellitus (T1DM) and Multiple Sclerosis (MS)- first case of MAP eradication with cure of CD used UVBI – Role in complex Regional Pain Syndrome (CRPS) 14 TARGETS BLOOD-BORNE DISEASES SUCH AS HEPATITIS C, HIV/AIDS, H1N1 14 Private and Confidential
  15. 15. The ImmunoModulator™ Concept • IM device exposes the patient’s whole blood to an Ultraviolet (UV) light source – Treatment process involves removing a small amount of blood (3-4%) from the patient, then exposing the blood to a precise amount of UV energy for a precise amount of time – During treatment, UV exposed cells activate the immune system resulting in immune modulation. – After exposure, the blood is returned to the patient through the same portal it was drawn from – The treated blood stimulates immune system cells. 15 15 Private and Confidential
  16. 16. The ImmunoModulator™ System • ImmunoModulator (IM) technology developed to utilize broad band ultraviolet light (200nm-400nm). • Unlike conventional drug therapies that appear to be limited by a patient's ethnicity and viral genotype, the IM is uniquely safe and highly effective for all ethnic groups and viral genotypes • Demonstrates favorable safety and efficacy profile of standard HCV and HIV treatments • No recorded severe adverse event (300 Procedures) • Potentially viable alternative or adjunctive treatment for a wide range of pathogens, “autoimmune” diseases and certain cancers 16 FIRST-IN-CLASS DEVICE 16 Private and Confidential
  17. 17. The ImmunoModulator™ System 17 17 Private and Confidential USE IMAGE FROM POSTER
  18. 18. Clinical Studies/Data Data to date: • Hepatitis C – Granted two IDE approvals by FDA for human non-responder trials – Safety and efficacy data from first trial sufficient to initiate second • Human HIV – Early results suggest reduction in viral load and stable CD4 counts • H1N1/Influenza A – Pre-clinical research conducted at the request of the U.S. Food and Drug Administration – Initial results suggests device inhibited viruses and reduced inflammation in the lungs • Psoriasis – Two HCV study patients had prior histories of moderate and severe psoriasis. Both patients experienced long term reduced symptoms. 18 STUDIES PREVIOUSLY CONDUCTED IN MULTIPLE INDICATIONS 18 Private and Confidential
  19. 19. Future • Influenza Study • Mycobacterium Avian Complex (MAC) Study 19 19 Private and Confidential Mechanism of Action • Viral Diseases • Bacterial Diseases • Immune Deficiencies such as Crohn's Disease and Psoriasis
  20. 20. 20 • Todd Kuenstner, CEO and Chief Medical Officer. Dr Kuenstner is a pathologist who is currently the Medical Director or Clinical Laboratories at the Charleston Area Medical Center in Charleston, West Virginia. Previously, he was the Director of Clinical Chemistry for Aurora Health Care in southeastern Wisconsin. He received his pathology training at the Walter Reed Army Medical Center in Washington, D.C.. In addition to being a practicing physician Dr. Kuenstner is an inventor and holds several patents pertaining to non-invasive hemoglobin and carboxy-hemoglobin testing. • Frank R. Bonanni, President. BS Chemistry from Fairleigh Dickinson University. Experience includes Corporate Vice President International Development at CRBard, Inc., Vice President Business Development and CEO at North American Sterilization and Packaging. • Kenneth R. Cohen, Esq. General Counsel. Graduated from Rutgers University and New York University School of Law. Kenneth R. Cohen is a member of the law firm of Davidson, Sochor, Ragsdale & Cohen, LLC. His practice includes business law, estate planning, and administration, asset protection and elder law with special emphasis in taxation. • Dennis A. Losco, Vice President of Operations. Graduated from Fairleigh Dickinson with a BS degree in Mechanical Engineering in 1967. Joining Superior Quartz Products in 1969 as head of their engineering department, he has been designing medium pressure lamps for forty five years. Inventor of a platform based multiple foil high current seal for medium pressure lamps. He has served as President of Superior Quartz Products since 1995. Confidential Officers
  21. 21. 21 • Dennis J. Losco, Controller. Graduated from Farleigh Dickinson in 1991 with a degree in Business Management. Joined Superior Quartz Products, Inc in 1991 and has held several positions of increasing responsibility, including Director of Sales and Corporate Treasurer. Assumed responsibility of controller at AVIcure in 2013. • Jeffry W. Losco, Vice President of Mechanical Engineering. Lafayette College - 1993 - BS Mechanical Engineering. Superior Quartz Products - 1988-Present - VP and Director of Engineering. Co-Inventor of Patent for Cup Seal Design for Foil-less high current medium pressure lamp. Co-Inventor of Patent for Discharge Lamp with Self Supporting Electrode Structures. Avicure Bioscience - 2013-Present - Vice President of Mechanical Engineering and Chairman of Science Committee. • Joseph W Losco, Vice President of Electrical Engineering. Graduated from Bucknell University, Cum Laude, with a degree in Electrical Engineering in 2004. After graduation began working at Superior Quartz Products, Inc. as the Director of Electrical Engineering. In 2013, he joined AVIcure as Vice President of Electrical Engineering. • Roger R. Marvinney Sr., Vice President of Marketing. Over 20 years of building sales and marketing organizations in Silicon Valley high technology companies with an initial background in corporate finance at a global NY financial institution. Mr. Marvinney has established a very successful record in venture funded start-ups and is responsible for developing North American Sterilization and Packaging's core business as well as building the new medical device technology incubator business for North American Sterilization and Packaging. • Thomas Petrie, Vice President of Technology. The inventor of the ImmunoModulator and HemaSterilizer technologies. He has spent his entire career in the medical device industry where he has held senior management positions at Becton Dickenson, Data Scope, and Personal Diagnostics. His involvement with UVBI technologies exceeds 20 years. Confidential Officers
  22. 22. 22 • Preston A. Marx, PhD. He is a Professor of Tropical Medicine at the Tulane School of Public Health and Tropical Medicine, the Tulane National Primate Research Center, and a member of the AIDS Research Advisory Committee, National Health Institute. • Dr. Konstantin “Gus” Kousoulas, PhD. He is the Director of Biotechnology and Molecular Medicine (BIOMMED) at Louisiana State University, School of Veterinary Medicine and the LSU- Tulane NIH COBRE Center for Experimental Infectious Disease Research. • Noshir Mehta Professor and Chair. Asst Dean at Tufts Dental School; Assoc. Dean International Relations; Chair. General Dentistry and Director Craniofacial Pain center at Tufts University School of Dental Medicine • Stuart Weg, MD. Stuart Weg, MD has 30 years' experience in anesthesiology and pain management. His practice evolved from mainstream pain management to use alternative therapies to treat many chronic diseases and other types of imbalances that have been difficult to treat effectively with conventional medicine. Dr. Weg received his medical doctorate from the University of Monterrey in Mexico and completed an internship at Memorial Sloan Kettering Cancer Center as well as an anesthesia residency at Beth Israel Hospital Medical Center with the New York Mount Sinai Medical School. He also completed a preceptorship in Invasive Pain Management under the Chair of Anesthesiology at Texas Tech University. Confidential Advisers

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